40052 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

Background and Brief Description 

Section 2(a) of Public Law 102–493 

(known as the Fertility Clinic Success 

Rate and Certification Act of 1992 

(FCSRCA), 42 U.S.C. 263a–1(a)) requires 

that each assisted reproductive 

technology (ART) program shall 

annually report to the Secretary through 

the Centers for Disease Control and 

Prevention: (1) Pregnancy success rates 

achieved by such ART program, and (2) 

the identity of each embryo laboratory 

used by such ART program, and 

whether the laboratory is certified or has 

applied for such certification under the 

Act. The required information is 

currently reported by ART programs to 

CDC as specified in the Assisted 

Reproductive Technology (ART) 

Program Reporting System (OMB 

Control No. 0920–0556, Exp. 8/31/ 

2021). CDC seeks to continue OMB 

approval for a period of three years. The 

revised total burden estimate is higher 

than the previous approval, due to an 

increase in the utilization of ART in the 

United States. 

The estimated number of respondents 

(ART programs or clinics) is 456, based 

on the number of clinics that provided 

information in 2018; the estimated 

average number of responses (ART 

cycles) per respondent is 670. 

Additionally, approximately 5–10% of 

responding clinics will be randomly 

selected each year to participate in data 

validation and quality control activities; 

an estimated 35 clinics will be selected 

to report validation data on 70 cycles 

each on average. Finally, respondents 

may provide feedback to CDC about the 

usability and utility of the reporting 

system. The option to participate in the 

feedback survey is presented to 

respondents when they complete their 

required data submission. Participation 

in the feedback survey is voluntary and 

is not required by the FCSRCA. CDC 

estimates that 50% of ART programs 

will participate in the feedback survey. 

The collection of ART cycle 

information allows CDC to publish an 

annual report to Congress as specified 

by the FCSRCA and to provide 

information needed by consumers. OMB 

approval is requested for three years and 

there are no costs to respondents other 

than their time. The total estimated 

annualized burden is 219,904 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

ART Clinics ..................................................... NASS Reporting Form ................................... 456 670 43/60 

Data Validation ............................................... 35 70 23/60 

Feedback Survey ........................................... 255 1 2/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–15791 Filed 7–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–21–1238] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘US 

Tuberculosis Follow-Up Worksheet for 

Newly-Arrived Persons with Overseas 

Tuberculosis Classifications,’’ also 

commonly known as a ‘‘TB Follow-Up 

Worksheet’’ to the Office of 

Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on 03/09/ 

2021 to obtain comments from the 

public and affected agencies. CDC 

received one comment related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

The US Tuberculosis Follow-Up 

Worksheet for Newly-Arrived Persons 

with Overseas Tuberculosis 

Classifications (OMB Control No. 0920– 

1238, Exp. 06/30/2021)—Reinstatement 

with Change—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Division of Global Migration and 

Quarantine (DGMQ) collaborated with 

the Division of TB Elimination (DTBE) 

to revise the proposed worksheet to 

capture follow-up medical examination 

information after a person with 

tuberculosis classification has arrived in 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40053 

the US. The overseas medical 

examination determines whether the 

applicant has an inadmissible condition 

of public health significance (a Class A 

condition) or has a health-related 

condition that is admissible, but might 

require extensive medical treatment or 

follow-up (a Class B condition), such as 

treated tuberculosis. Applicants with 

Class A (inadmissible) conditions can 

only enter the United States if they are 

granted a waiver. Applicants who have 

Class A conditions include those who; 

(1) Have a communicable disease of 

public health significance, (2) do not 

have documentation of having received 

vaccinations against vaccinepreventable diseases, (3) have a physical 

or mental disorder with associated 

harmful behavior, or (4) abuse, or are 

addicted to drugs (42 U.S.C. 252, 8 

U.S.C. 1182, and 8 U.S.C. 1222 provide 

for the physical and mental examination 

of applicants in accordance with 

regulations prescribed by the HHS 

Secretary). CDC highly recommends that 

persons with overseas class A or B 

tuberculosis receive domestic follow-up 

medical examination information to 

prevent new transmission of 

tuberculosis. This is the primary 

rationale for collecting domestic 

tuberculosis follow-up information. 

The US foreign-born population 

continuously had the highest incidence 

of tuberculosis compared to the US nonforeign-born population. According to 

CDC, the 2019 TB case rate was 14.2 per 

100,000 for foreign-born persons 

compared to 0.9 per 100,000 for USborn persons. The proportion of TB 

cases occurring in the foreign-born 

population was found to be 

approximately 70.9% of the national 

case total. CDC strongly recommends 

US-bound immigrants and refugees with 

class A or B tuberculosis to receive 

follow-up examinations for tuberculosis 

in the US. 

The purpose of this data collection is 

to methodically gather tuberculosis 

follow-up outcome data to monitor and 

track US-bound persons with overseas 

class A and B tuberculosis to assist in 

the national effort to prevent new 

transmission of tuberculosis. To 

accurately determine recent US arrivals 

receiving domestic follow-up medical 

examinations, US health departments 

will provide domestic follow-up 

outcome information to CDC by 

completing The EDN Tuberculosis 

Follow-Up Worksheet for NewlyArrived Persons with Overseas 

Tuberculosis Classifications, also 

commonly known as the TB Follow-Up 

Worksheet. Without this data, DGMQ 

will not have a method of tracking and 

monitoring newly-arrived persons with 

overseas class A or B tuberculosis. 

DGMQ will use information reported on 

the TB Follow-Up Worksheet to ensure 

that tuberculosis programs are 

effectively tracking newly-arrived 

persons and coordinating follow-up 

medical examinations with state and 

local clinicians in the US. 

Since the previous approval of the 

‘‘US Tuberculosis Follow-Up Worksheet 

for Newly-Arrived Persons with 

Overseas Tuberculosis Classifications’’ 

data collection instrument in 2018, 

there have been changes made in the 

data collection instrument to clarify 

wording, add additional options for 

respondents to select, and enhance data 

collection quality. There are also 

clarifications made in the ‘‘Purpose and 

Use of Information Collection’’ in 

Supporting Statement A to further 

clarify information what the data 

collection instrument collects. In the 

‘‘Respondent Universe and Sampling 

Methods’’ section of Supporting 

Statement B, there are clarifications 

made to explain how respondents gain 

access to and use the Electronic Disease 

Notification (EDN) system and the data 

collection instrument. There is an 

increase from 550 respondents to 1548 

respondents due to the increase in the 

number of individuals throughout the 

United States requesting access to the 

EDN system to access medical records 

for U.S. arrivals, and complete the EDN 

Tuberculosis Follow-Up Worksheet for 

Newly-Arrived Persons with Overseas 

Tuberculosis Classifications for U.S. 

arrivals with TB classifications. There is 

no change to the burden per respondent 

to complete a follow-up form. 

Several indicators will be calculated 

to measure domestic tuberculosis 

program performance, including the 

percentage of aliens with class B 

tuberculosis with complete US medical 

examinations. This program 

performance monitoring activity will be 

ongoing throughout the year. State and 

local health departments will 

voluntarily report evaluation outcome 

findings on a continuous basis once 

evaluation results for an individual 

becomes available. 

Data collected by DGMQ will be used 

to help evaluate the efficacy and 

efficiency of overseas tuberculosis 

diagnoses, treatments, and prevention 

activities along with panel physician 

performance. Currently, DGMQ does not 

have an effective method of determining 

the accuracy of chest x-rays read 

overseas and the aptness of overseas 

treatment for tuberculosis. This data 

will provide DGMQ with a method of 

evaluating panel physician performance 

and overseas treatment and prevention 

activities. The proposed TB Follow-Up 

Worksheet contains sections that allow 

US physicians to review overseas chest 

x-rays and treatment and indicate any 

concerns or errors. A negative 

consequence of not collecting this 

information is that DGMQ will not be 

able to efficiently analyze data to 

determine which panel physicians have 

the most inaccuracies. Plans for formal 

evaluations of US panel physicians are 

contingent upon the approval of the TB 

Follow-Up Worksheet. 

If technical instructions for 

tuberculosis diagnosis and treatment are 

followed properly overseas, persons 

with overseas classification B 

tuberculosis should not have 

tuberculosis disease during their US 

follow-up examinations. The form will 

help DGMQ understand what factors 

may contribute to a domestic diagnosis 

of tuberculosis. The TB Follow-up 

Worksheet contains a section that 

collects patient diagnoses and treatment 

recommendations. Without this 

information, DGMQ staff will not be 

able to accurately identify and resolve 

factors that contribute to tuberculosis 

disease. This form of monitoring is 

ongoing and will occur with every 

instance an alien is diagnosed with 

tuberculosis disease during follow-up 

examinations. 

There are no costs to the respondents 

other than their time. The total 

estimated annual burden are 2,322 

hours. 


jbell on DSKJLSW7X2PROD with NOTICES
40054 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

EDN data entry staff at state and local health 

departments.

US Tuberculosis Follow-up Worksheet for 

Newly-Arrived Persons with Overseas Tuberculosis Classifications.

1,548 3 30/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–15793 Filed 7–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Health Statistics 

(NCHS), ICD–10 Coordination and 

Maintenance (C&M) Committee 

Meeting 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The CDC, National Center for 

Health Statistics (NCHS), Classifications 

and Public Health Data Standards Staff, 

announces the following meeting of the 

ICD–10 Coordination and Maintenance 

(C&M) Committee meeting. This 

meeting is open to the public, limited 

only by audio. Online Registration is not 

required. 

DATES: The meeting will be held on 

September 14, 2021, from 9:00 a.m. to 

5:00 p.m., EDT, and September 15, 

2021, from 9:00 a.m. to 5:00 p.m., EDT. 

ADDRESSES: This is a virtual meeting. 

Information will be provided on each of 

our respective web pages when it 

becomes available. For CDC/NCHS 

https://www.cdc.gov/nchs/icd/icd10cm_

maintenance.htm. For CMS https://

www.cms.gov/Medicare/Coding/ 

ICD9ProviderDiagnosticCodes/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Traci Ramirez, Medical Systems 

Specialist, CDC, 3311 Toledo Road, 

Hyattsville, Maryland 20782; 

Telephone: (301) 458–4454; Email: 

TRamirez@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The ICD–10 Coordination 

and Maintenance (C&M) Committee is a 

public forum for the presentation of 

proposed modifications to the 

International Classification of Diseases, 

Tenth Revision, Clinical Modification 

and ICD–10 Procedure Coding System. 

Matters To Be Considered: The 

tentative agenda will include 

discussions on ICD–10–CM and ICD– 

10–PCS topics listed below. Agenda 

items are subject to change as priorities 

dictate. 

Please refer to the posted agenda for 

updates one month prior to the meeting. 

ICD–10–PCS Topics 

1. Administration of fostamatinib(1), (2) 

2. Administration of betibeglogene 

autotemcel (beti-cel)(1) 

3. Administration of RBX2660(1) 

4. Pressure-controlled Intermittent 

Coronary Sinus Occlusion 

5. Measurement of Exhaled Nitric Oxide 

(FeNo) 

6. Histotripsy of Liver 

7. Replacement of Meniscus with 

Synthetic Substitute (1) 

8. Section X Updates 

9. Addenda and Key Updates 

(1) Applicant intends to submit a New 

Technology Add-on Payment (NTAP) 

application for FY 2023. 

(2) Request is for an April 1, 2022 

implementation date. 

Presentations for procedure code 

requests are conducted by both the 

requestor and CMS during the 

Coordination & Maintenance Committee 

meeting. Discussion from the requestor 

generally focuses on the clinical issues 

for the procedure or technology, 

followed by the proposed coding 

options from a CMS analyst. Topics 

presented may also include requests for 

new procedure codes that relate to a 

new technology add-on payment 

(NTAP) policy request. 

CMS is continuing to modify the 

approach for presenting the new 

technology add-on payment (NTAP) 

related ICD–10–PCS procedure code 

requests that involve the administration 

of a therapeutic agent. Consistent with 

the requirements of section 

1886(d)(5)(K)(iii) of the Social Security 

Act, applicants submitted requests to 

create a unique procedure code to 

describe the administration of a 

therapeutic agent, such as the option to 

create a new code in Section X within 

the ICD–10–PCS procedure code 

classification. CMS will initially only 

display those meeting materials 

associated with the NTAP related ICD– 

10–PCS procedure code requests that 

involve the administration of a 

therapeutic agent on the CMS website in 

early August 2021 at: https://

www.cms.gov/Medicare/Coding/ICD10/ 

C-and-M-Meeting-Materials. 

The three NTAP related ICD–10–PCS 

procedure code requests that involve the 

administration of a therapeutic agent 

are: 

1. Administration of fostamatinib 

2. Administration of betibeglogene 

autotemcel (beti-cel) 

3. Administration of RBX2660 

These topics will not be presented 

during the September 14–15, 2021 

meeting. CMS will solicit public 

comments regarding any clinical 

questions or coding options included for 

these three procedure code topics in 

advance of the meeting continuing 

through the end of the public comment 

period. The deadline to submit 

comments for topics being considered 

for April 1, 2022 implementation is 

October 15, 2021 and the deadline to 

submit comments for topics being 

considered for an October 1, 2022 

implementation is November 15, 2021. 

Members of the public should send any 

questions or comments to the CMS 

mailbox at: ICDProcedureCodeRequest@

cms.hhs.gov by the designated deadline 

dates mentioned above. 

CMS intends to post a question and 

answer document in advance of the 

meeting to address any clinical or 

coding questions that members of the 

public may have submitted. Following 

the conclusion of the meeting, CMS will 

post an updated question and answer 

document to address any additional 

clinical or coding questions that 

members of the public may have 

submitted during the meeting that CMS 

was not able to address or that were 

submitted after the meeting. 

The NTAP related ICD–10–PCS 

procedure code requests that do not 

involve the administration of a 

therapeutic agent and all non-NTAP 

related procedure code requests will 

continue to be presented during the 

virtual meeting on September 14, 2021 


jbell on DSKJLSW7X2PROD with NOTICES